Phenylephrine / promethazine Side Effects

Some side effects of phenylephrine / promethazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to phenylephrine / promethazine: oral syrup

If you experience any of the following serious side effects, stop taking phenylephrine and promethazine and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

• uncontrollable movements of the eyes, lips, tongue, face, arms, or legs.

Other, less serious side effects may be more likely to occur. Continue to take phenylephrine and promethazine and talk to your doctor if you experience

• dizziness, drowsiness, sleepiness, or confusion;

• restlessness or irritability;

• blurred vision or a dry mouth;

• nausea or vomiting; or

• increased skin sensitivity to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to phenylephrine / promethazine: oral syrup

Cardiovascular

Cardiovascular side effects have included increased or decreased blood pressure.

Nervous system

Nervous system side effects have included sedation, sleepiness, dizziness, confusion, disorientation, restlessness, anxiety, nervousness, tremor, weakness, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion.

Ocular

Ocular side effects have included blurred vision.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, and vomiting.

Hematologic

Hematologic side effects have included rare cases of leukopenia, thrombocytopenia, and agranulocytosis.

Dermatologic

Dermatologic side effects have included rash and rarely photosensitivity.

Respiratory

Respiratory side effects have included respiratory distress.

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